Ignite Creation Date:
2024-05-05 @ 11:39 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00107445
Status:
COMPLETED
Last Update Posted:
2013-01-16
First Post:
2005-04-05
Brief Title:
EF5 in Finding Oxygen in Tumor Cells of Patients Who Are Undergoing Surgery or Biopsy for Cervical Endometrial or Ovarian Epithelial Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Evaluation of Hypoxia by EF5 Binding in Gynecologic Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well EF5 works in finding oxygen in tumor cells of patients who are undergoing surgery or biopsy for cervical endometrial or ovarian epithelial cancer Diagnostic procedures using the drug EF5 to find oxygen in tumor cells may help in planning cancer treatment
Detailed Description:
PRIMARY OBJECTIVES
I Correlate the level of EF5 binding with pre-treatment hemoglobin level and tumor grade and stage in patients undergoing surgery or biopsy for cervical endometrial or ovarian epithelial cancer
SECONDARY OBJECTIVES
I Correlate pre-treatment tumor hypoxia as measured by EF5 binding with time to progression and time to recurrence in these patients
II Correlate EF5 binding with CD-31 expression tumor vasculature Ki-67 expression cellular proliferation and erythropoietin signaling in these patients
OUTLINE
Patients receive EF5 IV over 1-2½ hours on day 1 Approximately 1-2 days later patients undergo tumor resection or biopsy Patients tumor tissue samples undergo immunohistochemistry and flow cytometry to detect EF5 binding levels Patients blood is drawn immediately before and 30-60 minutes and 1-2 days after receiving EF5 to measure systemic EF5 binding levels
Patients are followed at 30-45 days after administration of EF5 and then every 3-6 months thereafter
I Correlate the level of EF5 binding with pre-treatment hemoglobin level and tumor grade and stage in patients undergoing surgery or biopsy for cervical endometrial or ovarian epithelial cancer
SECONDARY OBJECTIVES
I Correlate pre-treatment tumor hypoxia as measured by EF5 binding with time to progression and time to recurrence in these patients
II Correlate EF5 binding with CD-31 expression tumor vasculature Ki-67 expression cellular proliferation and erythropoietin signaling in these patients
OUTLINE
Patients receive EF5 IV over 1-2½ hours on day 1 Approximately 1-2 days later patients undergo tumor resection or biopsy Patients tumor tissue samples undergo immunohistochemistry and flow cytometry to detect EF5 binding levels Patients blood is drawn immediately before and 30-60 minutes and 1-2 days after receiving EF5 to measure systemic EF5 binding levels
Patients are followed at 30-45 days after administration of EF5 and then every 3-6 months thereafter
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000419673 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchR21CA099346 |
| UPCC-03804 | None | None | None |
| R21CA099346 | NIH | None | None |